Gall StoneNCT06692517
Benchmarks in Elective Laparoscopic Cholecystectomy
An observational study of Gall Stone and Gallbladder Inflammation, run by Region Östergötland.
Trial summary
The aim of this observational cohort study is to define peri- and postoperative reference values for elective laparoscopic cholecystectomy, using the achievable benchmarks of care methodology (ABC™). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gall Stone, Gallbladder Inflammation, Gall Bladder Pain
- What is being tested?
- Laparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 60,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 31 Dec 2023
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with gall stone disease and, or previous gallbladder inflammation.
Who may be able to join
- adults ≥ 18 years of age
- laparoscopic primary cholecystectomy
Who cannot join
- patients with current acute cholecystitis, pancreatitis or cholangitis
- cholecystectomy due to malignancy
- other organ surgery performed at the same occasion
- previous upper gastrointestinal surgery
- single port access
- robotic surgery
- no data concerning surgical intervention
About this study
Official title: Benchmarks in Elective Laparoscopic Cholecystectomy - a National Registry Study
The aim of this observational cohort study is to define peri- and postoperative reference values for elective laparoscopic cholecystectomy, using the achievable benchmarks of care methodology (ABC™). Another aim is to develop adjusted reference values for groups with a risk factor of severe postoperative complications. The over-arching aim is to inspire quality improvement initiatives.
Read the detailed description
The data source is the Swedish patient registry GallRiks, a prospective quality registry for gallbladder surgery and endoscopic retrograde cholangio-pancreatography (ERCP). The time frame will be 2015-2023. Register variables related to surgical quality will be analyzed, such as postoperative complications, perioperative adverse events, surgical duration and length of stay. The study will analyze data for the time of surgery and up to 30 days afterwards. Since the data is not yet available to the researchers the number of enrolled study participants can not be specified with certitude; therefore an anticipated number is given.
- Conditions
- Gall Stone, Gallbladder Inflammation, Gall Bladder Pain, Gallstone, Gall Stones (& [Calculus - Gall Bladder])
- Being tested
- Laparoscopic cholecystectomy
- Keywords
- Laparoscopic cholecystectomy, Benchmarking, Surgical Outcomes, Reference values, Quality Improvement, Risk factors of surgical complications
- Medical subject headings
- Gallstones, Cholecystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic cholecystectomyProcedure or surgery
Laparoscopic cholecystectomy
| Study group | Role | What they receive |
|---|---|---|
| Elective cholecystectomy | Elective cholecystectomy. Patients with recurrent gallstone attacks, previous cholecystitis, previous cholangitis, or previous pancreatitis. ERCP may be involved if a gallstone is detected in the common bile duct perioperatively. Receives: Procedure: Laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Benchmark values of elective laparoscopic cholecystectomy
The study will use the ABC methodology to identify reference values of surgical duration (minutes), perioperative cholangiography, conversion to open surgery and adverse events
Measured: Day of surgery
Postoperative benchmark values of elective laparoscopic cholecystectomy
The study will use the ABC methodology to identify reference values of the postoperative variables: hospital length of stay (days), abscess/infection, bleeding, biliary leakage, readmission, reoperation
Measured: 0-30 days after surgery
Secondary outcomes (1)
Adjusted benchmarks for severe complications
Univariable and multivariable logistic regression analysis will be performed to detect any risk factor for severe complications after laparoscopic cholecystectomy. The factors to be investigated are body mass index (kg/m2), age (years), gender, smoking, cardiovascular disease, pulmonary disease, diabetes, immunosuppressive treatment, and treatment with anticoagulants. Adjusted benchmarks will be calculated for factor(s) that in multivariable logistic regression analysis are identified as individual risk factor(s).
Measured: 0-30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start1 Jan 2015
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gall StoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 60,000 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Region Östergötland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebba Kihlstedt Pasquier, Region Östergötland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06692517
- Sponsor's protocol ID
- 2022-04311-01
- Status last verified
- Dec 2024
- First submitted
- 3 May 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benchmarks in Elective Laparoscopic Cholecystectomy - a National Registry Study
- ClinicalTrials.gov ID
- NCT06692517
- Acronym / sponsor ID
- 2022-04311-01
- Conditions
- Gall Stone, Gallbladder Inflammation, Gall Bladder Pain, Gallstone, Gall Stones (& [Calculus - Gall Bladder])
- Keywords
- Laparoscopic cholecystectomy, Benchmarking, Surgical Outcomes, Reference values, Quality Improvement, Risk factors of surgical complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60,000 participants (estimated)
- Lead sponsor
- Region ÖstergötlandUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 18 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this observational cohort study is to define peri- and postoperative reference values for elective laparoscopic cholecystectomy, using the achievable benchmarks of care methodology (ABC™). Another aim is to develop adjusted reference values for groups with a risk factor of severe postoperative complications. The over-arching aim is to inspire quality improvement initiatives.
Detailed description
The data source is the Swedish patient registry GallRiks, a prospective quality registry for gallbladder surgery and endoscopic retrograde cholangio-pancreatography (ERCP). The time frame will be 2015-2023. Register variables related to surgical quality will be analyzed, such as postoperative complications, perioperative adverse events, surgical duration and length of stay. The study will analyze data for the time of surgery and up to 30 days afterwards. Since the data is not yet available to the researchers the number of enrolled study participants can not be specified with certitude; therefore an anticipated number is given.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elective cholecystectomy | – | Procedure: Laparoscopic cholecystectomyElective cholecystectomy. Patients with recurrent gallstone attacks, previous cholecystitis, previous cholangitis, or previous pancreatitis. ERCP may be involved if a gallstone is detected in the common bile duct perioperatively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with gall stone disease and, or previous gallbladder inflammation.
Key inclusion criteria (2 listed)
- adults ≥ 18 years of age
- laparoscopic primary cholecystectomy
Key exclusion criteria (7 listed)
- patients with current acute cholecystitis, pancreatitis or cholangitis
- cholecystectomy due to malignancy
- other organ surgery performed at the same occasion
- previous upper gastrointestinal surgery
- single port access
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic cholecystectomyLaparoscopic cholecystectomy | Procedure or surgery | Elective cholecystectomy |
Primary outcome
Benchmark values of elective laparoscopic cholecystectomy
Time frame: Day of surgery
The study will use the ABC methodology to identify reference values of surgical duration (minutes), perioperative cholangiography, conversion to open surgery and adverse events
Postoperative benchmark values of elective laparoscopic cholecystectomy
Time frame: 0-30 days after surgery
The study will use the ABC methodology to identify reference values of the postoperative variables: hospital length of stay (days), abscess/infection, bleeding, biliary leakage, readmission, reoperation
1 secondary outcome
Adjusted benchmarks for severe complications
Time frame: 0-30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Individual participant dataSharing planned: Undecided. Data will be shared upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Gall Stone and Gallbladder Inflammation, run by Region Östergötland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Benchmark values of elective laparoscopic cholecystectomy (time frame: Day of surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024.